EUCTR2017-005019-15-AT进行中（未招募）1 期
A Phase II, single arm, multicenter open label trial to determine the safety and efficacy of tisagenlecleucel in pediatric patients with relapsed or refractory mature B-cell non-Hodgkin lymphoma (NHL) (BIANCA) - BIANCA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Signed informed consent and assent forms if applicable must be obtained prior to participation in the study.
- •2.Histologically confirmed (local evaluation) mature B-cell non-Hodgkin lymphoma (B-cell NHL) including the following subtypes; Burkitt Lymphoma and Burkitt Leukemia (L3 B-ALL) (BL), Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-Cell Lymphoma (PMBCL), Gray Zone lymphoma (GZL), and Follicular Lymphoma (FL).
- •a. Note: Patients with B-cell NHL associated with Nijmegen breakage
- •syndrome will be allowed.
- •b. Sufficient formalin-fixed, paraffin-embedded (FFPE) tumor sample
- •must be available for correlative analyses. A recent tumor sample
- •obtained for the purpose of the study must be submitted, however if not clinically feasible, an archival tumor biopsy from the most recent relapse or other historical sample may be submitted instead. Excisional biopsies should be submitted wherever possible; in cases where this is not possible a core needle biopsy is allowed. Fine needle aspiration (FNA) is not suitable.
- •3. Patients =25 years of age and weighing at least 6 kg at the time of
- •4.Patients who have relapsed after one or more prior therapies (can
- •include allogeneic and autologous hematopoietic stem cell transplant) or are primary refractory (have not achieved a CR or PR after the first line of therapy).
- •5. Measurable disease by radiological criteria in all patients at the time of screening. Patients with Burkitt leukemia who don't meet radiological criteria must have bone marrow involvement of >25%.
- •6. Karnofsky (age =16 years) or Lansky (age <16 years) performance
- •status =60.
- •7. Adequate bone marrow reserve without transfusions defined as:
- •a. Absolute neutrophil count (ANC) >1000/mm3
- •b. Platelets =50000//mm3
- •c. Hemoglobin =8.0 g/dl
- •Note: These criteria do not apply for subjects with Burkitt leukemia.
- •8. Adequate organ function:
- •a.a serum creatinine (sCR) based on gender/age as described in detail
- •the protocol
- •b.AST (aspartate aminotransferase) and ALT (alanine aminotransferase) =5 times the upper limit of normal (ULN) for age.
- •c.Bilirubin <1.5 x ULN (for Gilbert's Syndrome patients total bilirubin <4 mg/dL).
- •d.Adequate pulmonary function
- •i.Oxygen saturation of >91% on room air.
- •ii.No or mild dyspnea (=Grade 1)
- •9.Must have a leukapheresis material of non-mobilized cells accepted for manufacturing. Note: Leukapheresis material will not be shipped to or assessed for acceptance by the manufacturing site until documented confirmation of all other eligibility criteria is received.
- •Other protocol-defined inclusion criteria may apply.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Prior gene therapy or engineered T cell therapy
- •2.Prior treatment with any anti-CD19 therapy
- •3.Allogeneic hematopoietic stem cell transplant (HSCT) <3 months prior to screening and =4 months prior to infusion
- •4.Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD) in patients who received prior allogeneic HSCT.
- •5.Prior diagnosis of malignancy other than study indication, and not disease free for 5 years
- •6.Clinically significant active infection confirmed by clinical evidence,
- •imaging, or positive laboratory tests (e.g., blood cultures, PCR for DNA/RNA, etc.)
- •7. Presence of active hepatitis B or C as indicated by serology. Repeat serology is required if the interval between serology performed at
- •screening and tisagenlecleucel infusion exceeds 8 weeks.
- •8.Human Immunodeficiency Virus (HIV) positive test. Repeat serology is required if the interval between serology performed at screening and tisagenlecleucel infusion exceeds 8 weeks
- •9.Active neurological autoimmune or inflammatory disorders not related to B cell NHL (e.g., Guillain-Barre syndrome, Amyotrophic Lateral Sclerosis)
- •10.Active CNS involvement by malignancy. Note: Patients with history of CNS disease that have been effectively treated will be eligible.
- •11.Patients with B-cell NHL in the context of post-transplant
- •lymphoproliferative disorders (PTLD) associated lymphomas.
- •12.Patients with concomitant genetic syndromes associated with bone marrow failure status such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Note: Patients with Down syndrome will not be excluded.
- •13. Known hypersensitivity to the excipients of tisagenlecleucel or to any other drug product as advised for administration in the study protocol (e.g. lymphodepleting agents, tocilizumab).
- •14.Cardiac disorder defined as:
- •a.Cardiac or cardiac repolarization abnormality, including any of the
- •i.History of myocardial infarction (MI), angina pectoris, or coronary
- •artery bypass graft (CABG) within 6 months prior to starting study
- •ii.Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block
- •(e.g., bifascicular block, Mobitz type II and third degree AV block)
- •b.LVEF <45% as determined by ECHO or MRA or MUGA
- •c.NYHA functional class III or IV
- •15.Subjects enrolled in this study are not permitted to participate in
- •additional parallel investigational drug or device studies
- •16.Pregnant or nursing (lactating) women.
- •Note: Women of child-bearing potential must have a negative serum
- •pregnancy test performed at screening, within 24 hours prior to leukapheresis, within 24 hours prior to lymphodepletion Serum or urine, within 24 hours prior to tisagenlecleucel infusion and at EOS.
- •17. Women of child-bearing potential, defined as all women
- •physiologically capable of becoming pregnant, unless they are using
- •highly effective methods of contraception from enrollment into this
- •study through at least 12 months after the tisagenlecleucel infusion and until CAR-T cells are no longer present by qPCR on two consecutive tests. qPCR test results will be available upon request.
- •18. Sexually active males who do not agree to use a condom during
- •intercourse from enrollment through at least 12 months after the
- •tisagenlecleucel infusion and until CAR-T cells are no longer present by
- •qPCR on two consecutive tests. qPCR test results will be available upon
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